Nintedanib (BIBF 1120) in Mesothelioma



Status:Terminated
Conditions:Lung Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:3/20/2019
Start Date:September 19, 2013
End Date:August 31, 2018

Use our guide to learn which trials are right for you!

LUME-Meso: Double Blind, Randomised, Multicentre, Phase II/III Study of Nintedanib in Combination With Pemetrexed / Cisplatin Followed by Continuing Nintedanib Monotherapy Versus Placebo in Combination With Pemetrexed / Cisplatin Followed by Continuing Placebo Monotherapy for the Treatment of Patients With Unresectable Malignant Pleural Mesothelioma

This is a phase II/III confirmatory study designed to evaluate the safety and efficacy of
nintedanib (BIBF 1120) in combination + (pemetrexed / cisplatin) followed by nintedanib (BIBF
1120) versus placebo + pemetrexed / cisplatin followed by placebo for the treatment of
patients with unresectable malignant pleural mesothelioma.


Inclusion criteria:

- Histologically confirmed malignant pleural mesothelioma (MPM) (Epithelioid or biphasic
subtype for Phase II patients; epithelioid subtype only for Phase III patients)

- Life expectancy of at least 3 months in the opinion of the investigator

- Eastern Cooperative Oncology Group (ECOG) score of 0 or 1

- Measurable disease according to modified RECIST (Response Evaluation Criteria In Solid
Tumours) criteria

Exclusion criteria:

- Previous systemic chemotherapy for MPM

- Prior treatment with nintedanib or any other prior line of therapy

- Phase II patients with sarcomatoid subtype MPM or Phase III patients with biphasic or
sarcomatoid subtype MPM

- Patients with symptomatic neuropathy

- Radiotherapy (except extremities) within 3 months prior to baseline imaging

- Active brain metastases (e.g. stable for < 4 weeks)

- Radiographic evidence of cavitary or necrotic tumours or local invasion of major blood
vessels by MPM

- Significant cardiovascular diseases

- Inadequate hematologic, renal, or hepatic function
We found this trial at
11
sites
1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
?
mi
from
Birmingham, AL
Click here to add this to my saved trials
1240 Francisco Acuña de Figueroa
Ciudad Autónoma de Bs As, C1180
?
mi
from
Ciudad Autónoma de Bs As,
Click here to add this to my saved trials
Greenville, South Carolina 29615
?
mi
from
Greenville, SC
Click here to add this to my saved trials
?
mi
from
Henderson, NV
Click here to add this to my saved trials
1515 Holcombe Blvd
Houston, Texas 77030
 713-792-2121
University of Texas M.D. Anderson Cancer Center The mission of The University of Texas MD...
?
mi
from
Houston, TX
Click here to add this to my saved trials
Littleton, Colorado 80120
?
mi
from
Littleton, CO
Click here to add this to my saved trials
McAllen, Texas 78503
?
mi
from
McAllen, TX
Click here to add this to my saved trials
200 Lothrop St
Pittsburgh, Pennsylvania 15213
University of Pittsburgh Medical Center UPMC is one of the leading nonprofit health systems in...
?
mi
from
Pittsburgh, PA
Click here to add this to my saved trials
San Antonio, Texas 78217
?
mi
from
San Antonio, TX
Click here to add this to my saved trials
San Francisco, California 94143
?
mi
from
San Francisco, CA
Click here to add this to my saved trials
1204 North Vercler Road
Spokane Valley, Washington 99216
?
mi
from
Spokane Valley, WA
Click here to add this to my saved trials